Clinical Documentation & Systems Specialist (Clinical R&D)

Position

We are seeking a collaborative and dynamic Clinical Documentation & Systems Specialist to administer and manage Eikon Therapeutics’ electronic Document Management System, Learning Management System and Clinical System.  This role will ensure strict adherence to GxP standards for document control of GxP procedural documents as well as management of training assignments and training records.  The Clinical Documentation & Systems Specialist will also be responsible for adherence to data standards by ensuring accurate and consistent global data collection and curation in Eikon’s Clinical Trial Management System.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our Jersey City (NJ), New York (NY), or Millbrae (CA) offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

About You

You are extremely detail-oriented and work well with others.  You enjoy managing a variety of tasks simultaneously, actively seek out opportunities to learn, and understand the importance of adherence to regulatory requirements and standards.  You are knowledgeable and comfortable with technology and have experience with database management. 

What You’ll Do

Document Control Job Duties

• Maintain access control, versioning and lifecycle management of GxP procedural documents within the Document Management System
• Support the Quality Management System (QMS)
• Perform Document Control administrative tasks in the document management system, including processing change requests, routing documents for approval, and publishing approved documents
• Perform reviews to maintain quality standards in document formats and conformance to document templates
• Collaborate with document authors on the development of new documents
• Coordinate periodic review activities
• Maintain the Standard Operating Procedure Glossary
• Participate in system upgrades and or configuration changes as required  

Training Job Duties

• Collaborate with functional area leaders to maintain the training matrix and curricula
• Create training requirements and assign required training to employees
• Create and manage course quizzes
• Manage training records, including collection and period review of CVs, job descriptors and training certificates
• Generate and distribute training compliance reports
• Participate in system upgrades and or configuration changes as required 

CTMS-related Job Duties

• Support maintenance of organization and personnel data in Global Directory
• Ensure accurate and consistent global data collection and curation through adherence to internal data standards
• Generate clinical reports and perform quality checks of expected vs actual data entered
• Collaborate with study teams to resolve data queries
• Participate in system upgrades and or configuration changes as required 

Qualifications

• Typically requires a minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work experience.
• Experience managing electronic document management systems and document control processes preferred. 
• Sound working knowledge of Good Clinical Practice (GCP).
• Demonstrated knowledge of Microsoft Office
• Excellent verbal and written communication skills.
• Team-oriented individual with the ability to effectively work within a team environment.
• Experience with Veeva

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

• 401k plan with company matching​
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)​
• Mental health and wellness benefits​
• Weeklong summer and winter holiday shutdowns​
• Generous paid time off and holiday policies​
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies ​
• Enhanced parental leave benefit​
• Daily subsidized lunch program when on-site​

The expected salary range for this role is $113,000 to $123,500 depending on skills, competency, and the market demand for your expertise.